NCT04932174

Brief Summary

The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 13, 2021

Last Update Submit

June 13, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Assessing the change in body Weight

    Assessment via using body weight scale with height (m) scale to be able to calculate body mass index (Kg) to all subjects before starting the study BMI= Weight (KG) /Height2 (M2)

    Baseline and 2 months post-intervention

  • Assessing the change in Waist hip ratio

    Assessment via using was measured to the nearest 0.1 cm by using a flexible steel tape at the level of umbilicus, and hip circumference (HC) was measured at the widest level over the greater trochanters.

    Baseline and 2 months post-intervention

  • Assessing the change in body fat

    Assessment through bioelectrical impedance analysis by using a Body Composition Analyzer (TANITA Corporation, Japan).

    Baseline and 2 months post-intervention

  • Assessing the change Cardiorespiratory fitness

    Assessment via using Shuttle run test The 20-m shuttle run (20MSR) test, also called the ''Course Navette'', "PACER", or "Multistage fitness test", is probably the most widely used field test for estimating cardiorespiratory fitness.

    Baseline and 2 months post-intervention

Study Arms (2)

High-intensity Interval Training

EXPERIMENTAL

Group 2: the included 15 subjects will participate in High intensity Interval training exercise running on treadmill for 12 weeks, 3 times / week.

Other: High-intensity Interval Training

Low-intensity Continuous Training

ACTIVE COMPARATOR

Group 1: the included 15 subjects will participate in low intensity continuous exercise on treadmill for 12 weeks, 3 times / week

Other: Low-intensity Continuous Training

Interventions

Consisting of the following program: * Warming up period for 10 minutes at 60-70% of HR max. * Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval. * Duration of HIIT 4 minute * Number of interval per session 4 * Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min.

High-intensity Interval Training

Consisting of the following program: * Warming up period for 10 minutes. * Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks. * cooling down period for 10 minutes.

Low-intensity Continuous Training

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) will be ≥ 25 -29.9 kg/m².
  • Age will be ranging from 20 to 30 years.
  • Waist circumference \>88cm2 in men and \>102cm2 in women.
  • Content of body fat will be assisted by electrical bioimpedence≥33%.
  • Stable body weight in the month prior to the trial.
  • Follow instructions for healthy life style.

You may not qualify if:

  • Patients with musculoskeletal deformities and disorders.
  • Patients with other neuromuscular disorders.
  • Patients with foot deformities and ulcers.
  • Patients with lower limb operations.
  • Smoking cigarettes, thyroid diseases.
  • History of coronary artery disease Asthma, chronic obstructive pulmonary diseases.
  • poorly controlled hypertension (mean systolic blood pressure (SBP) \> 140 mm Hg and/or mean diastolic blood pressure (DBP) \> 90 mm Hg) during the month prior to the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Horus University

Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Heba Yasser, Demonstrator

    Horus University in Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba Yasser, Demonstrator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2021

First Posted

June 21, 2021

Study Start

April 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 15, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations